The Effect of a Short Term Exercise Schedule on Oral Iron... | NCT01730521

Studies
The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation

NCT01730521

Sponsor

Swiss Federal Institute of Technology

Status

Completed

Last Update Posted

Sep 13, 2013Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Generally Healthy

Interventions

Exercise (Running)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Jun 2013Actual

First Submitted Date

Nov 7, 2012

First Submission Date that Met QC Criteria

Nov 15, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2013

Last Update Posted Date

Sep 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Michael B. Zimmermann, Professor, MD, Swiss Federal Institute of TechnologyPrincipal Investigator

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Iron metabolism may undergo changes during exercise, with reductions in classical iron status markers due to a variety of postulated mechanism which include hemodilution, increased iron loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin levels may reduce iron bioavailability and iron incorporation in erythrocytes.

Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be generally healthy, with no history of blood donation in the last 6 months, should weigh less than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should have familiarity to sports and running, but not currently (i.e. in the past 3 months) training for more than 1h per week on average.

The aim of this study is to measure an iron bioavailability during a resting and an exercise phase lasting approx. 14 days with training sessions on alternate days. Subjects will participate in both restign and exercising protocols and act as their own controls during the study. Iron bioavailability will be measured via the incorporation of stable isotopic labels 14 days after administration. To control for changes in blood volume during the course of the study, blood volume of the participating subjects will be measured before and after the exercise phase with the CO-rebreathing method.

Measurement of iron bioavailability and iron incorporation in a resting and exercising phase will allow determine if the increased level of hepcidin seen in in exercise will induce a lower iron bioavailability and iron incorporation during exercise.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Difference in Iron bioavailabilty exercise and resting phase		the subjects will act as their own control during the study	Behavioral: Exercise (Running)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise (Running)	Behavioral	the study foresees a measurement of iron biavailability in a resting and in a exercising phase and subjects will act as their own control during the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Iron bioavailability from Stable isotopic labels		Up to 2 months

Secondary Outcomes

Measure	Description	Time Frame
Blood volume increase during exercise		Up to 2 months

Other Outcomes

Measure	Description	Time Frame
Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein)		Up to 2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men, Generally Healthy age between 18-50 years;
BMI between 18-25;
nonanemic (Hb < 120 g/L);
no intake of vitamins and nutritional supplements;
no recent blood donation (<4 months);
no previous participation in studies with stable iron isotopes in the past.

Exclusion Criteria:

Chronic diseases, Metabolic diseases, GI tract diseases (self reported)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Subjects studying or working at the University of Zürich or ETH Zürich

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diego Moretti, PhD	ETH Zürich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ETH Zürich		Zurich		8092	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20926522	Background	Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6.
30351387

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

ID	Term
D015444	Exercise
D012420	Running